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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00156026
Other study ID # OCOG-2000-CIN1
Secondary ID
Status Completed
Phase Phase 3
First received September 8, 2005
Last updated January 28, 2009
Start date November 2000
Est. completion date September 2007

Study information

Verified date January 2009
Source Ontario Clinical Oncology Group (OCOG)
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaBrazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

This study looks at immediate treatment of a cervix with CIN 1 versus regular six-month follow-up with colposcopy and treatment if CIN 1 progresses.


Description:

In women who present with biopsy-proven CIN 1, to compare the management approach of regular colposcopic follow-up and only treating progressive disease using the LEEP, with an approach of immediate treatment using LEEP. The primary outcome is progression to more advanced disease (i.e., CIN 2, CIN 3 or cancer).


Recruitment information / eligibility

Status Completed
Enrollment 415
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Female
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Eligible patients will:

- have documented CIN 1 by histologic assessment as the highest grade lesion present,

- have the lesion confined to the cervix and completely visualized,

- be 16 years or older.

Exclusion Criteria:

- any one of the following will be an excluding characteristic:

- index Pap smear showing CIN 2, CIN 3 or cancer;

- index Pap smear shows atypical glandular cells of unknown significance, glandular dysplasia, or malignancy requiring immediate investigation;

- patients with previously identified CIN 1 by biopsy who are already in a colposcopic surveillance program;

- unsatisfactory colposcopic exam defined as inability to see the extent of the lesion in the endocervical canal or absence of a lesion on the ectocervix but endocervical curettage shows CIN 1;

- pregnancy;

- prior therapy for dysplasia including medical (5FU), surgical (Laser, LEEP) or cryotherapy;

- prior gynecologic cancer;

- prior pelvic radiation therapy;

- inability to attend outpatient follow-up visits because of geographic inaccessibility;

- other malignancies except non-melanoma skin cancer;

- immunosuppression due to diseases such as AIDS, organ transplantation, or on immunosuppressive medications such as prednisone, imuran or chemotherapy for diseases like systemic lupus;

- cognitively impaired or otherwise unable to obtain written informed consent;

- extension of the CIN 1 lesion to vagina or a separate vaginal lesion showing dysplasia;

- colposcopically visible condyloma outside of the transformation zone;

- known allergy to local analgesics;

- clinically evident vaginitis must be treated and resolved prior to entry on the trial;

- inability to read and respond in English/French;

- failure to provide informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
loop electrosurgical excision procedure (LEEP)
1. loop electrosurgical excision procedure

Locations

Country Name City State
Brazil Universidade Estadual de Campinas Campinas
Brazil Instituto Fernandes Figueira - Oswaldo Cruz Foundation Rio de Janeiro
Canada Brantford General Hospital Brantford Ontario
Canada Nova Scotia Cancer Centre Halifax Nova Scotia
Canada Hamilton Health Sciences - Henderson Site Hamilton Ontario
Canada London Health Sciences Centre London Ontario
Canada Hôpital du Saint-Sacrement Quebec
Canada University of Saskatchewan Saskatoon Saskatchewan
Canada St. Michael's Hospital Toronto Ontario
Canada B.C. Cancer Agency Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
Ontario Clinical Oncology Group (OCOG) Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

Brazil,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary progression to more advanced disease 18 months Yes
Secondary persistent CIN 1 after 18 months 18 months Yes
Secondary bleeding. 18 months Yes
Secondary predict disease persistence or progression 18 months No
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